Ins and Outs of Design, Development, and Review

Inputs and outputs can be rather confusing when it comes to their meanings in a quality management system (QMS) or in an ISO standard. The ins of experience and the outs of future correction is a short way to look at the difference.

It would make sense that the ins are what is put into something and the outs are what is taken out, which is close to what the standard says but there are a few clarifications that are needed to explain the specifics.

There are two sections in ISO 9100c that use inputs and outputs, the management responsibility/management review section and the product realization/design and development section.

Inputs in design and development are what the products is suppose to be with all of the requirements, regulation, previous information and how to develop the product. Inputs for management review are all the things that could possibly go or did go wrong such as: corrective action, preventative action, putting audits in place, customers reviews, previous review actions, and improvement to the system.

Inputs are documents that exist from experience of the product in design, regulation, and review.Inputs are about the same as, what went wrong or right with the product(s) or system(s) and how to change the scope to correct the system.

Outputs for a product are specifications that it is safe, built with the right materials, and clarification on how to use such an item. Management reviews outputs are steps to improve product given customer’s needs, improvement of the quality system as a whole, and a review of resources.

Outputs in design and development are a list of safety instructions from the product(s), but for management review, outputs are steps to improve the product(s) itself the system and resources understanding that as customer’s needs change, the system will need tightening and the resources can change given supplier or availability of material(s).

In general inputs are those documents gathered from experience of what is being done, and outputs are it realization and overall improvement given the experience of what is being done and changes that will need to happen given different parameters.

A quality management system that is not in conformance with ISO standard could have some of these terms, such as inputs and outputs, meaning something else than what they do in the ISO standard. Conformity to the standard and certification by the standard are both good, but having the certification to prove you are in conformance is of a higher quality.

We at K & S Quality Associates work both with the inputs and outputs of a QMS. If you or your company is interested in internal auditor training, internal audits, or building a QMS, please email contact@qualityassociates.com.

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